Diabetic NeuropathiesDISNEY-T2DMNCT06573684
Differences In The Severity Of Diabetic Neuropathy Based On Electromyography In Type 2 Diabetes Mellitus Patients With And Without Comorbidities
An observational study of Diabetic Neuropathies, run by Universitas Diponegoro at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn the differences severity level of diabetic neuropathy based on electromyelography in type II diabetic patient with and without comorbidities. The main questions of this study: 1. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Electromyography
- How many people
- 78 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2024to 1 Aug 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Adult, Older adult
Study population: Patient with type II diabetic mellitus who suffered diabetic neuropathy which diagnosed by using electromyography and fulfill the eligibility criteria
Who may be able to join
- Diabetic neuropathy patient who classified as distal symmetrical polyneuropathy
- Diabetic neuropathy patient who has no comorbidities
- Diabetic neuropathy patient who has hypertension
- Diabetic neuropathy patient who has hypertension and dyslipidemia
Who cannot join
- Diabetic neuropathy patient with history of chemotherapy
- Diabetic neuropathy patient with history of hernia nucleus pulposus
- Diabetic neuropathy patient with history of CKD stage V or on routine dyalisis
- Missing data on medical record
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Kariadi Central General Hospital
Semarang, Central of Java
About this study
The goal of this clinical trial is to learn the differences severity level of diabetic neuropathy based on electromyelography in type II diabetic patient with and without comorbidities. The main questions of this study:
- What is the electromyography result in type II diabetic patient who: has no comorbidities, with hypertension, with hypertension and dyslipidemia?
- Is there any differences in electromyography result in type II diabetic patient who: has no comorbidities, with hypertension, with hypertension and dyslipidemia?
- Is there any association between distal latency with nerve conduction velocity in type II diabetic patient with and without comorbidities?
- Is there any association between distal latency with amplitude in type II diabetic patient with and without comorbidities?
- Is there any differences on diabetic neuropathy severity based on age, height, and A1C levels in type II diabetic patient with and without comorbidities?
Researchers will collect information based on hospital registry as secondary data of in type II diabetic patient with and without comorbidities. The data consist of demographic data, clinical presentation, laboratory, and electromyography were collected from hospital registry by reviewing medical record. Then, the data was analyzed by using IBM SPSS Statistics v26.
- Conditions
- Diabetic Neuropathies
- Being tested
- Electromyography
- Keywords
- Type II diabetic mellitus, Diabetic neuropathy, Electromyography
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectromyographyDiagnostic test
All of groups will have assessment of electromyography result
| Study group | Role | What they receive |
|---|---|---|
| Type II Diabetic Mellitus without comorbidities | Patient who suffered diabetic neuropathy and history of type II diabetic mellitus without comorbidities Receives: Diagnostic Test: Electromyography | |
| Type II Diabetic Mellitus with hypertension | Patient who suffered diabetic neuropathy and history of type II diabetic mellitus with hypertension Receives: Diagnostic Test: Electromyography | |
| Type II Diabetic Mellitus with hypertension and dyslipidemia | Patient who suffered diabetic neuropathy and history of type II diabetic mellitus with hypertension and dyslipidemia Receives: Diagnostic Test: Electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distal Latency
Distal latency defined as time between stimuli until deflection of Compound Muscle Action Potentials (CMAP) from baseline
Measured: Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear
Secondary outcomes (2)
Nerve Conduction Velocity
Nerve Conduction Velocity defined as the measurement of axon conduction velocity by dividing space of nerve conduction with time needed
Measured: Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear
Amplitude
Amplitude define as the height of first negative deflection of Compound Muscle Action Potentials (CMAP) from baseline
Measured: Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Universitas Diponegoro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Widiastuti, Prof, Universitas Diponegoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573684
- Sponsor's protocol ID
- Undip_Neuro
- Acronym
- DISNEY-T2DM
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lu Y, Xing P, Cai X, Luo D, Li R, Lloyd C, Sartorius N, Li M. Prevalence and Risk Factors for Diabetic Peripheral Neuropathy in Type 2 Diabetic Patients From 14 Countries: Estimates of the INTERPRET-DD Study. Front Public Health. 2020 Oct 20;8:534372. doi: 10.3389/fpubh.2020.534372. eCollection 2020.
PubMed 33194943England JD, Gronseth GS, Franklin G, Miller RG, Asbury AK, Carter GT, Cohen JA, Fisher MA, Howard JF, Kinsella LJ, Latov N, Lewis RA, Low PA, Sumner AJ; American Academy of Neurology; American Association of Electrodiagnostic Medicine; American Academy of Physical Medicine and Rehabilitation. Distal symmetric polyneuropathy: a definition for clinical research: report of the American Academy of Neurology, the American Association of Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2005 Jan 25;64(2):199-207. doi: 10.1212/01.WNL.0000149522.32823.EA.
PubMed 15668414
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences In The Severity Of Diabetic Neuropathy Based On Electromyography In Type 2 Diabetes Mellitus Patients With And Without Comorbidities
- ClinicalTrials.gov ID
- NCT06573684
- Acronym / sponsor ID
- DISNEY-T2DM / Undip_Neuro
- Conditions
- Diabetic Neuropathies
- Keywords
- Type II diabetic mellitus, Diabetic neuropathy, Electromyography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Universitas DiponegoroUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn the differences severity level of diabetic neuropathy based on electromyelography in type II diabetic patient with and without comorbidities. The main questions of this study:
- What is the electromyography result in type II diabetic patient who: has no comorbidities, with hypertension, with hypertension and dyslipidemia?
- Is there any differences in electromyography result in type II diabetic patient who: has no comorbidities, with hypertension, with hypertension and dyslipidemia?
- Is there any association between distal latency with nerve conduction velocity in type II diabetic patient with and without comorbidities?
- Is there any association between distal latency with amplitude in type II diabetic patient with and without comorbidities?
- Is there any differences on diabetic neuropathy severity based on age, height, and A1C levels in type II diabetic patient with and without comorbidities?
Researchers will collect information based on hospital registry as secondary data of in type II diabetic patient with and without comorbidities. The data consist of demographic data, clinical presentation, laboratory, and electromyography were collected from hospital registry by reviewing medical record. Then, the data was analyzed by using IBM SPSS Statistics v26.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type II Diabetic Mellitus without comorbidities | – | Diagnostic Test: ElectromyographyPatient who suffered diabetic neuropathy and history of type II diabetic mellitus without comorbidities |
| Type II Diabetic Mellitus with hypertension | – | Diagnostic Test: ElectromyographyPatient who suffered diabetic neuropathy and history of type II diabetic mellitus with hypertension |
| Type II Diabetic Mellitus with hypertension and dyslipidemia | – | Diagnostic Test: ElectromyographyPatient who suffered diabetic neuropathy and history of type II diabetic mellitus with hypertension and dyslipidemia |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with type II diabetic mellitus who suffered diabetic neuropathy which diagnosed by using electromyography and fulfill the eligibility criteria
Key inclusion criteria (4 listed)
- Diabetic neuropathy patient who classified as distal symmetrical polyneuropathy
- Diabetic neuropathy patient who has no comorbidities
- Diabetic neuropathy patient who has hypertension
- Diabetic neuropathy patient who has hypertension and dyslipidemia
Key exclusion criteria (4 listed)
- Diabetic neuropathy patient with history of chemotherapy
- Diabetic neuropathy patient with history of hernia nucleus pulposus
- Diabetic neuropathy patient with history of CKD stage V or on routine dyalisis
- Missing data on medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectromyographyAll of groups will have assessment of electromyography result | Diagnostic test | Type II Diabetic Mellitus with hypertension, Type II Diabetic Mellitus with hypertension and dyslipidemia, Type II Diabetic Mellitus without comorbidities |
Primary outcome
Distal Latency
Time frame: Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear
Distal latency defined as time between stimuli until deflection of Compound Muscle Action Potentials (CMAP) from baseline
2 secondary outcomes
Nerve Conduction Velocity
Time frame: Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear
Amplitude
Time frame: Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Background: PubMed 33194943Lu Y, Xing P, Cai X, Luo D, Li R, Lloyd C, Sartorius N, Li M. Prevalence and Risk Factors for Diabetic Peripheral Neuropathy in Type 2 Diabetic Patients From 14 Countries: Estimates of the INTERPRET-DD Study. Front Public Health. 2020 Oct 20;8:534372. doi: 10.3389/fpubh.2020.534372. eCollection 2020.
- Background: PubMed 15668414England JD, Gronseth GS, Franklin G, Miller RG, Asbury AK, Carter GT, Cohen JA, Fisher MA, Howard JF, Kinsella LJ, Latov N, Lewis RA, Low PA, Sumner AJ; American Academy of Neurology; American Association of Electrodiagnostic Medicine; American Academy of Physical Medicine and Rehabilitation. Distal symmetric polyneuropathy: a definition for clinical research: report of the American Academy of Neurology, the American Association of Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2005 Jan 25;64(2):199-207. doi: 10.1212/01.WNL.0000149522.32823.EA.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Neuropathies, run by Universitas Diponegoro at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distal Latency (time frame: Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06573684, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.